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    Patrick Trucchio • H.C. Wainwright & Co., LLC

    Patrick Trucchio's questions to Altimmune Inc (ALT) leadership

    Patrick Trucchio's questions to Altimmune Inc (ALT) leadership • Q2 2025

    Question

    Patrick Trucchio from H.C. Wainwright & Co. asked about the potential Phase 3 dosing and endpoint strategy for pemvidutide in NASH. He also inquired about the drug's prospective commercial positioning and key points of differentiation if Phase 3 results mirror the IMPACT trial's efficacy and tolerability profile.

    Answer

    Chief Medical Officer Dr. M. Scott Harris indicated the 2.4mg dose is attractive for Phase 3 and that various endpoint strategies are being considered for FDA discussion. CEO Dr. Vipin Garg highlighted the key commercial differentiators as the combination of direct liver action with weight loss, a class-leading safety profile, and the lack of need for dose titration.

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    Patrick Trucchio's questions to Altimmune Inc (ALT) leadership • Q4 2024

    Question

    Patrick Trucchio of H.C. Wainwright & Co. requested more details on the triple reader model for the IMPACT trial, the specific start date for the Phase III MASH trial, and how the MASH program would be sequenced with trials in other indications.

    Answer

    CMO Dr. Scott Harris detailed the 3-reader 'mode' approach and blinded rereads, designed to control the placebo effect, and confirmed a Phase III start is anticipated in Q1 2026 following a year-end end-of-Phase II meeting. CEO Dr. Vipin Garg added that the smaller proof-of-concept trials for new indications are running in parallel and can be sequenced easily without delaying the primary MASH Phase III program.

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    Patrick Trucchio's questions to Arrowhead Pharmaceuticals Inc (ARWR) leadership

    Patrick Trucchio's questions to Arrowhead Pharmaceuticals Inc (ARWR) leadership • Q3 2025

    Question

    Patrick Trucchio inquired about payer access for FCS, potential coverage differentiation for SHTG patients, and the expected pricing relationship between the FCS and SHTG indications.

    Answer

    CEO Christopher Anzalone addressed pricing, stating that while they are not ready to provide a specific price for the SHTG indication, they would expect it to be priced lower than for the rare disease FCS indication.

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    Patrick Trucchio's questions to Arrowhead Pharmaceuticals Inc (ARWR) leadership • Q2 2025

    Question

    Patrick Trucchio of H.C. Wainwright & Co. asked about the strategic positioning of the ARO-C3 and ARO-CFB programs and whether they are considered core assets or potential partnering opportunities.

    Answer

    An executive stated the company is open to partnerships for ARO-C3 and Factor B if the right economics can be found. Chief Medical Officer, Dr. James Hamilton, added that ARO-C3 data in IgAN shows a competitive 41% reduction in proteinuria, which, combined with infrequent dosing, could be advantageous.

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    Patrick Trucchio's questions to Arrowhead Pharmaceuticals Inc (ARWR) leadership • Q1 2025

    Question

    Patrick Trucchio asked for a review of plozasiran's competitive positioning against olozarsen in both FCS and SHTG. He also inquired about attractive targets and disease areas for the company's adipose tissue-targeting platform.

    Answer

    Andy Davis, Head of Global Cardiometabolic Franchise, highlighted plozasiran's differentiation through deeper triglyceride reduction, achieving risk thresholds, a statistically significant reduction in pancreatitis risk, and convenient quarterly dosing. Dr. Bruce Given added that the SHTG market will be expanded by both companies. Dr. James Hamilton noted obesity, type 2 diabetes, and lipodystrophy as target indications for the adipose platform but did not disclose specific targets.

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    Patrick Trucchio's questions to Immunocore Holdings PLC (IMCR) leadership

    Patrick Trucchio's questions to Immunocore Holdings PLC (IMCR) leadership • Q2 2025

    Question

    Patrick Trucchio of H.C. Wainwright & Co. asked for clarification on whether ChemTrak's growth was driven more by new patients or longer treatment durations, and inquired about the criteria for initiating the expansion cohort in the HIV program.

    Answer

    Ralph Torbay, EVP of Commercial, explained growth was driven by both, but primarily by increased market penetration, with duration of therapy providing a tailwind. David Berman, EVP of R&D, stated the HIV expansion would be triggered by demonstrating viral control beyond the initial 12-week protocol and identifying the right dose, building on exciting early signals.

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    Patrick Trucchio's questions to Immunocore Holdings PLC (IMCR) leadership • Q4 2024

    Question

    Patrick Trucchio from H.C. Wainwright & Co. inquired if the HIV MAD data could suggest a combination strategy for M113V and whether the program might qualify for priority review or other accelerated development pathways.

    Answer

    David Berman, Head of R&D, confirmed that the platform is combinable and the ultimate goal is a finite dosing regimen allowing patients to stop all therapies. He stated that while regulatory incentives like priority review are a consideration for the future, it is too early to comment on them before generating more definitive data.

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    Patrick Trucchio's questions to Vir Biotechnology Inc (VIR) leadership

    Patrick Trucchio's questions to Vir Biotechnology Inc (VIR) leadership • Q2 2025

    Question

    Patrick Trucchio of H.C. Wainwright & Co. sought clarification on the U.S. regulatory filing strategy for HDV, the primary purpose of the ECLIPSE-3 head-to-head trial, and how the VIR-5525 study is designed to capture data in KRAS mutant tumors.

    Answer

    EVP & Chief Medical Officer Dr. Mark Eisner reiterated that the base case for U.S. filing is ECLIPSE-1 and -2, but using ECLIPSE-1 and SOLSTICE remains an option. He confirmed ECLIPSE-3 is primarily to support European payer negotiations by demonstrating superiority over bulevirtide. EVP of Oncology Dr. Mika Derynck explained that the VIR-5525 trial will enroll patients who have exhausted standard care, including KRAS inhibitors, and emphasized that the T-cell engager's mechanism is independent of downstream mutations like KRAS.

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    Patrick Trucchio's questions to Vir Biotechnology Inc (VIR) leadership • Q1 2025

    Question

    Patrick Trucchio asked a series of questions regarding the CHB program's functional cure rate targets, the regulatory submission plan for the HDV program, and the company's partnering strategy for both the CHB and preclinical PRO-XTEN programs.

    Answer

    Mark Eisner (Executive) confirmed that for CHB, the best responses were in patients with baseline surface antigen levels below 1,000. For HDV, he stated that data from ECLIPSE-1 and ECLIPSE-2 should be sufficient for a filing package under an accelerated approval pathway. Marianne De Backer (Executive) added that the preclinical PRO-XTEN strategy involves a mix of internal development for high-priority targets and partnerships for others.

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    Patrick Trucchio's questions to Vir Biotechnology Inc (VIR) leadership • Q4 2024

    Question

    Patrick Trucchio from H.C. Wainwright asked for any further learnings from the SOLSTICE HDV data that could inform the ECLIPSE program. He also inquired about the relative importance of reducing HB surface antigen in the HDV setting and how to think about this for the combination therapy versus monotherapy for long-term outcomes.

    Answer

    Dr. Mark Eisner, CMO, highlighted that learnings from the SOLSTICE trial about disease demographics have informed site and investigator selection for the ECLIPSE program to optimize Phase III. He emphasized the importance of the 3-log reduction in hepatitis B surface antigen seen with the combination therapy, stating it's critical for the delta virus life cycle. He expressed hope that this profound viral suppression will translate into better long-term outcomes for patients, such as less progression to cirrhosis.

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    Patrick Trucchio's questions to Vir Biotechnology Inc (VIR) leadership • Q3 2024

    Question

    Patrick Trucchio inquired about the expected differentiation of Vir's HDV combination therapy compared to bulevirtide. For the HBV program, he asked if the 20-30% functional cure targets apply to all-comers or a specific patient subset, and whether a Phase III trial might stratify patients by baseline S-antigen levels.

    Answer

    Dr. Mark Eisner, Chief Medical Officer, stated that Vir's HDV combo is expected to achieve much higher 'target not detected' rates than bulevirtide. He also expressed confidence in the response for patients switching from bulevirtide. For the HBV program, he deferred questions on patient stratification to the upcoming data presentation at the AASLD liver meeting.

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    Patrick Trucchio's questions to Harmony Biosciences Holdings Inc (HRMY) leadership

    Patrick Trucchio's questions to Harmony Biosciences Holdings Inc (HRMY) leadership • Q2 2025

    Question

    Patrick Trucchio from H.C. Wainwright & Co. requested details on the trial design for the upcoming pitolisant HD Phase 3 studies and inquired about the commercial launch strategy for ZYN-two, including community engagement and expected market uptake.

    Answer

    Chief Medical & Scientific Officer Dr. Kumar Budur described the pitolisant HD trials as standard randomized, placebo-controlled studies. Regarding the ZYN-two launch, EVP & CCO Adam Zaeske highlighted the high awareness and receptivity expected from the close-knit Fragile X community. President & CEO Dr. Jeffrey Dayno added that engaging with rare disease communities is a core strength of Harmony.

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    Patrick Trucchio's questions to Harmony Biosciences Holdings Inc (HRMY) leadership • Q1 2025

    Question

    Patrick Trucchio asked about the key drivers of the 2025 revenue guidance and for a preview of the upcoming Phase III trial designs for pitolisant HD, specifically if fatigue and sleep inertia would be powered endpoints.

    Answer

    CCO Adam Zaeske cited continued growth in patients on therapy as the primary driver for guidance. Dr. Kumar Budur, CMSO, confirmed the IH study design is set and the narcolepsy design will be shared later. He stated the goal is to eventually secure a fatigue indication for narcolepsy, supported by extensive ongoing research.

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    Patrick Trucchio's questions to Uniqure NV (QURE) leadership

    Patrick Trucchio's questions to Uniqure NV (QURE) leadership • Q2 2025

    Question

    Luis, on for Patrick Trucchio, asked about potential differences in the regulatory approval path for AMT-130 in Europe versus the U.S. and inquired about the patient population for the planned Phase II portion of the AMT-260 study.

    Answer

    CEO Matt Kapusta stated that uniQure has not yet met with the EMA regarding AMT-130 but plans to do so after the three-year data is available. CMO Walid Abi-Saab noted it's premature to detail the AMT-260 Phase II design but said a natural progression would be to study patients with dominant and bilateral disease, where the unmet need is highest.

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    Patrick Trucchio's questions to Uniqure NV (QURE) leadership • Q1 2025

    Question

    Patrick Trucchio asked if additional regulatory interactions are expected before the AMT-130 BLA filing and requested details on the three immunosuppression-related SAEs in Cohort 3, including any resulting protocol changes.

    Answer

    CEO Matthew Kapusta deferred specifics on future regulatory interactions until the formal update but reiterated confidence. CMO Dr. Walid Abi-Saab detailed that the three SAEs (mania, infection, fever) were related to the triple immunosuppression regimen, not AMT-130, and all resolved. He concluded that a short, 2-week course of corticosteroids is now considered the optimal immunosuppression strategy.

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    Patrick Trucchio's questions to Gossamer Bio Inc (GOSS) leadership

    Patrick Trucchio's questions to Gossamer Bio Inc (GOSS) leadership • Q1 2025

    Question

    Patrick Trucchio asked about the number of patients who discontinued sotatercept before entering PROSERA, the commercial implications of the open-label extension (OLE) data, the rationale for the doses in the PH-ILD study, and the potential impact of demonstrating a benefit on the underlying lung disease.

    Answer

    COO Bryan Giraudo noted a high single-digit number of sotatercept discontinuations. CCO Bob Smith and CEO Faheem Hasnain highlighted that the OLE data, showing continued improvement, is a key commercial differentiator supporting earlier use. For the PH-ILD trial, management explained the higher dose aims to increase drug exposure in the fibrotic lung, and success on the FVC endpoint would be a significant differentiator, particularly in Europe where no treatments are approved.

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    Patrick Trucchio's questions to Compass Pathways PLC (CMPS) leadership

    Patrick Trucchio's questions to Compass Pathways PLC (CMPS) leadership • Q1 2025

    Question

    Patrick Trucchio of H.C. Wainwright asked how to interpret the 52-week follow-up data for commercialization, if the pivotal program tracks concomitant medication use, and about the status of regulatory interactions for the PTSD program.

    Answer

    Dr. Steve Levine (CPO) emphasized that even 6-week durability would be a paradigm shift, with the 52-week data providing a strong signal. Dr. Guy Goodwin (CMO) confirmed that other medication use is tracked and adds a real-world element to the data. CEO Kabir Nath stated that while they will discuss PTSD plans with the FDA, they do not disclose specific feedback from regulatory interactions.

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    Patrick Trucchio's questions to Compass Pathways PLC (CMPS) leadership • Q4 2024

    Question

    Patrick Trucchio asked for context on what constitutes a clinically meaningful MADRS improvement and for details on the psychological support model, including how it differs from past approaches and its implications for regulatory approval and commercial scale-up.

    Answer

    Chief Medical Officer Dr. Guy Goodwin referenced the approximate 13-point MADRS change seen in the Phase II study as a positive benchmark. He explained the current psychological support model is simplified and protocolized to isolate the drug's effect for the FDA. Chief Commercial Officer Lori Englebert added that launch requirements are expected to be similar to SPRAVATO's REMS, while Chief Patient Officer Dr. Steve Levin noted they are leveraging partner collaborations to inform real-world training.

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    Patrick Trucchio's questions to Compass Pathways PLC (CMPS) leadership • Q3 2024

    Question

    Patrick Trucchio of H.C. Wainwright asked if both Phase III trials are still required for an NDA submission and if an FDA Advisory Committee (AdCom) is expected. He also inquired how the trial timeline changes might strengthen their position for a potential AdCom and how the COMP 005 data might read through to the COMP 006 trial.

    Answer

    Kabir Nath (Executive) confirmed that data from both trials are expected to be necessary for filing and that an AdCom is anticipated. An unnamed executive (Michael) added that protecting the blinding of the 006 study strengthens their regulatory position for an AdCom. He also noted that steps are being taken to prevent read-through from 005 to 006, such as not using overlapping trial sites.

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